Sanofi, Celgene on FDA Naughty List

The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) warned Sanofi-aventis and Celgene to stop broadcasting two of their television advertisements due to their misleading nature, according to Regulatory Affairs Professional Society (RAPS).

Both letters say: “The presentation of these compelling and attention-grabbing visuals, all of which are unrelated to the risk message presented in the audio and on-screen SUPERS [superimpositions], in addition to the frequent scene changes and the other competing modalities such as the background music, compete for the consumers’ attention. As a result, it is difficult for consumers to adequately process and comprehend the risk information.”

The FDA letter to Sanofi says the advertisement “makes false or misleading representations about the risks” associated with its diabetes treatment Toujeo (insulin glargine) while the Celgene letter is for the company’s advertisement for its psoriasis and psoriatic arthritis treatment Otezla (apremilast).

Both companies have until Dec. 27 to respond whether they intend to comply with the FDA’s requests.

Bayer has exercised its option, under a change-in-control clause in the collaboration agreement with Loxo Oncology, to obtain the exclusive licensing rights for the global development and commercialization of two cancer drugs.

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